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Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Primary Purpose

Stable Angina

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Diltiazem treated group
Bisoprolol treated group
Candesartan treated group
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
  • Unstable Angina/NSTEMI patients who completed PCI for main lesions
  • Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs

Exclusion Criteria:

  • STEMI patients within one month
  • Variant Angina
  • Liver function abnormality or renal failure
  • History of Hypersensitivity to testing drugs
  • Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
  • Woman possible to be pregnant
  • Uncontrolled diabetes
  • Expected life span < one year

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Diltiazem treated group

Bisoprolol treated group

Candesartan treated group

Arm Description

Diltiazem 180mg treated group

Bisoprolol 5mg treated group

Candesartan 32mg treated group

Outcomes

Primary Outcome Measures

Wall to lumen ratio of fundus vessel
Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up

Secondary Outcome Measures

lipid parameter
Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
Serum markers of inflammation
CRP
Change of nitrate need
Measure of change of nitrate need

Full Information

First Posted
April 30, 2010
Last Updated
December 15, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01162902
Brief Title
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Official Title
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diltiazem treated group
Arm Type
Experimental
Arm Description
Diltiazem 180mg treated group
Arm Title
Bisoprolol treated group
Arm Type
Active Comparator
Arm Description
Bisoprolol 5mg treated group
Arm Title
Candesartan treated group
Arm Type
Active Comparator
Arm Description
Candesartan 32mg treated group
Intervention Type
Drug
Intervention Name(s)
Diltiazem treated group
Intervention Description
Diltiazem 180mg for 9 months
Intervention Type
Drug
Intervention Name(s)
Bisoprolol treated group
Intervention Description
Bisoprolol 5mg for 9 months
Intervention Type
Drug
Intervention Name(s)
Candesartan treated group
Intervention Description
Candesartan 32mg for 9 months
Primary Outcome Measure Information:
Title
Wall to lumen ratio of fundus vessel
Description
Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up
Time Frame
baseline, 9 months
Secondary Outcome Measure Information:
Title
lipid parameter
Description
Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
Time Frame
baseline, 9 months
Title
Serum markers of inflammation
Description
CRP
Time Frame
baseline, 9 months
Title
Change of nitrate need
Description
Measure of change of nitrate need
Time Frame
baseline, 1 months, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI Unstable Angina/NSTEMI patients who completed PCI for main lesions Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs Exclusion Criteria: STEMI patients within one month Variant Angina Liver function abnormality or renal failure History of Hypersensitivity to testing drugs Severe heart failure(NYHA class>3) or uncorrectable hematologic disease Woman possible to be pregnant Uncontrolled diabetes Expected life span < one year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hae-Young Lee, MD, PhD
Phone
82-10-4528-6160
Email
hylee612@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo-Soo Kim, MD, PhD
Phone
82-2-2072-2226
Email
hyosoo@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hae-Young Lee, MD,PhD

12. IPD Sharing Statement

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Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

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